DE60127303T2 - WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT - Google Patents

WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT Download PDF

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Publication number
DE60127303T2
DE60127303T2 DE60127303T DE60127303T DE60127303T2 DE 60127303 T2 DE60127303 T2 DE 60127303T2 DE 60127303 T DE60127303 T DE 60127303T DE 60127303 T DE60127303 T DE 60127303T DE 60127303 T2 DE60127303 T2 DE 60127303T2
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Prior art keywords
dose
control unit
electronic control
button
injector
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DE60127303T
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German (de)
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DE60127303D1 (en
DE60127303T3 (en
Inventor
Christopher Nigel Langley
Shane Alistair Day
Robert Frederick Veasey
Robert Woolston
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DCA Design International Ltd
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DCA Design International Ltd
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588—Constructional features or modes of drive mechanisms for piston rods electrically driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/21—General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
    • A61M2205/215—Tilt detection, e.g. for warning or shut-off
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/01—Motorized syringe

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Fuel-Injection Apparatus (AREA)
  • Read Only Memory (AREA)
  • External Artificial Organs (AREA)
  • Knitting Machines (AREA)
  • Electrical Control Of Air Or Fuel Supplied To Internal-Combustion Engine (AREA)
  • Apparatus For Radiation Diagnosis (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Chemical Or Physical Treatment Of Fibers (AREA)
  • Diaphragms For Electromechanical Transducers (AREA)
  • Polarising Elements (AREA)
  • Coating Apparatus (AREA)
  • Electrophonic Musical Instruments (AREA)
  • Seal Device For Vehicle (AREA)
  • Valve Device For Special Equipments (AREA)
  • Elimination Of Static Electricity (AREA)
  • Vehicle Body Suspensions (AREA)
  • Loading And Unloading Of Fuel Tanks Or Ships (AREA)
  • Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
  • Transplanting Machines (AREA)
  • Catching Or Destruction (AREA)
  • Devices For Conveying Motion By Means Of Endless Flexible Members (AREA)

Abstract

An injection device having a drive mechanism to expel selectively a dose of medicament from a medicament cartridge through a needle unit is disclosed. The injection device further comprises an electronic control unit to control the drive mechanism, and a dispense button to generate a dispense button signal to the electronic control unit indicative of the dose to be expelled in which an arm button causes a first arm button signal to be sent to the electronic control unit to permit the dose to be expelled.

Description

Die vorliegende Erfindung betrifft Verbesserungen einer Injektionsvorrichtung und insbesondere Verbesserungen einer tragbaren Injektionsvorrichtung zur Abgabe kontrollierter Mengen eines Medikamentes.The The present invention relates to improvements to an injection device and in particular improvements of a portable injection device to deliver controlled amounts of a drug.

Solche Injektionsvorrichtungen werden typischerweise von Patienten verwendet, die an Diabetes leiden, um sich eine Dosis Insulin oder eines Medikamentes vom Insulintyp zu verabreichen. Es versteht sich, dass solche Injektionsvorrichtungen für die Injektion anderer Medikamente geeignet sind.Such Injection devices are typically used by patients who suffer from diabetes to get a dose of insulin or a drug of the insulin type. It is understood that such injection devices for the Injection of other drugs are suitable.

Solche Dosen wurden einmal durch Verwendung einer Einwegspritze verabreicht, wobei die Spritze zunächst aus einem separaten Gefäß oder einem anderen Behälter gefüllt und dann zur Injektion der Dosis verwendet wurde. Eine solche Anordnung barg jedoch eine Reihe von Schwierigkeiten. Insbesondere war eine solche Anordnung nicht für Schwache geeignet. Für andere machte das soziale Stigma in Verbindung mit solchen Spritzen deren Verwendung in der Öffentlichkeit problematisch.Such Doses were once administered by use of a disposable syringe, taking the syringe first from a separate vessel or one other container filled and then used to inject the dose. Such an arrangement barg but a series of difficulties. In particular, such was one Arrangement not for Weak suitable. For others made the social stigma associated with such injections their use in public problematic.

Um diese Schwierigkeiten zu überwinden, wurde eine Reihe so genannter schreibstiftartiger Injektoren entwickelt. Diese Vorrichtungen sind klein, können in einer Jackentasche oder dergleichen getragen werden und ermöglichen, dass eine Reihe von Dosen aus einer in dem Injektor enthaltenen Kartusche oder Ampulle erhalten werden. Die vorliegende Erfindung hat besondere Anwendung für solche schreibstiftartige Injektoren.Around to overcome these difficulties became developed a series of so-called pen-type injectors. These devices are small, can in a jacket pocket or the like, and allow a series of doses obtained from a cartridge or ampoule contained in the injector become. The present invention has particular application for such pen-type Injectors.

Solche schreibstiftartige Injektoren sind zwar eine erhebliche Verbesserung gegenüber Einweg-Subkutanspritzen, aber es bleiben dennoch Probleme bestehen. Es ist ein Vorteil der vorliegenden Erfindung, dass sie solche Probleme beseitigt oder wenigstens erheblich reduziert. Die vorliegende Erfindung bietet außerdem höhere Benutzerfreundlichkeit und bessere Interaktion mit einem Benutzer.Such Although pen-type injectors are a significant improvement across from Disposable hypodermic syringes, but there are still problems. It is an advantage of the present invention that they have such problems eliminated or at least significantly reduced. The present invention also offers higher Ease of use and better interaction with a user.

Die Erfindung wird nun lediglich beispielhaft unter Bezugnahme auf die begleitenden Zeichnungen beschrieben, die Folgendes zeigen:The Invention will now be described, by way of example only, with reference to the accompanying drawings Drawings describing:

1 zeigt eine Draufsicht auf einen schreibstiftartigen Injektor in Übereinstimmung mit der vorliegenden Erfindung; 1 shows a plan view of a pen-type injector in accordance with the present invention;

2 zeigt eine ähnliche Ansicht wie 1, wobei eine endständige Kappe des Injektors fehlt; 2 shows a similar view as 1 wherein a terminal cap of the injector is missing;

3 zeigt eine Querschnittansicht des Injektors von 1 und 2; und 3 shows a cross-sectional view of the injector of 1 and 2 ; and

3A zeigt eine ähnliche Ansicht wie 3 mit einer gefüllten Kartusche in dem Injektor. 3A shows a similar view as 3 with a filled cartridge in the injector.

Zunächst ist mit Bezug auf 1 bis 3 ein schreibstiftartiger Injektor 2 in Übereinstimmung mit der vorliegenden Erfindung zu sehen. Der Injektor 2 umfasst ein Hauptgehäuse 4, an dem lösbar eine Endkappe bzw. Abdeckung 6 befestigt ist.First, with respect to 1 to 3 a pen-type injector 2 in accordance with the present invention. The injector 2 includes a main body 4 , on which releasably an end cap or cover 6 is attached.

An einem ersten Ende des Hauptgehäuses 4 ist ein Steuerfeldbereich 8 bereitgestellt. Dieser Bereich umfasst ein Anzeigefeld 10, typischerweise eine LCD-Anzeige, und einen ersten Dosisknopf 12 und einen zweiten Dosisknopf 14, wobei der erste und zweite Dosisknopf betrieben werden, um eine zu verabreichende Dosis eines Medikamentes zu erhöhen oder zu verringern. Der Steuerfeldbereich 10 in der veranschaulichten Ausführungsform beinhaltet außerdem einen Aktivierungsknopf 16.At a first end of the main housing 4 is a control panel area 8th provided. This area includes a display field 10 , typically an LCD display, and a first dose button 12 and a second dose button 14 wherein the first and second dose buttons are operated to increase or decrease a dose of a medicament to be administered. The control panel area 10 in the illustrated embodiment also includes an activation button 16 ,

An dem ersten Ende des Hauptgehäuses ist außerdem ein Verabreichungsknopf 18 bereitgestellt. Der Verabreichungsknopf 18 ist vorzugsweise, wenn er nicht gedrückt ist, bündig zum Hauptgehäuse 4.At the first end of the main housing is also an administration button 18 provided. The administration button 18 is preferably, when it is not pressed, flush with the main body 4 ,

Entlang einer Längsachse des Injektors 2 ist an jeder Seite des Steuerfeldbereichs 10 eine Anzahl von Rillen oder Aussparungen 20 bereitgestellt. Diese helfen beim Greifen des Injektors 2 durch einen Benutzer.Along a longitudinal axis of the injector 2 is on each side of the panel 10 a number of grooves or recesses 20 provided. These help in grasping the injector 2 by a user.

An einem zweiten Ende des Hauptgehäuses 4 ist eine Nadeleinheit 22 lösbar an dem Hauptgehäuse befestigt. Das zweite Ende des Hauptgehäuses 4 ist außerdem mit einem geformten Anteil 24 ausgestattet.At a second end of the main body 4 is a needle unit 22 releasably attached to the main body. The second end of the main body 4 is also with a molded portion 24 fitted.

Zum Gebrauch wird eine Kartusche 40 oder Ampulle mit Medikament in dem Gehäuse 4 hinter dem geformten Anteil 24 aufbewahrt. Vorzugsweise ist der geformte Anteil durchsichtig, damit die Kartusche 40 von einem Benutzer gesehen werden kann.For use, a cartridge 40 or ampule with drug in the housing 4 behind the molded part 24 kept. Preferably, the shaped portion is transparent to allow the cartridge 40 can be seen by a user.

Am zweiten Ende des Gehäuses 4 ist außerdem ein Vorfüllknopf 26 bereitgestellt. Es versteht sich, dass wenn sich die Endkappe 6 über dem zweiten Ende des Gehäuses befindet, es nicht möglich ist, den Vorfüllknopf 26 versehentlich zu drücken oder von der Nadeleinheit 22 gestochen zu werden. Am zweiten Ende des Gehäuses 4 kann außerdem ein Abdeckungserkennungsschalter 28 enthalten sein, um zu erkennen, ob die Endkappe bzw. die Abdeckung 6 vorhanden ist oder nicht.At the second end of the case 4 is also a prefill button 26 provided. It is understood that when the end cap 6 located above the second end of the housing, it is not possible to use the priming button 26 accidentally to press or from the needle unit 22 to be stung. At the second end of the case 4 may also have a cover detection switch 28 be included to detect if the end cap or the cover 6 exists or not.

In 3 sind ein Vorfüllkontakt 30, ein Aktivierungskontakt 32, ein erster Dosiskontakt 34 und ein zweiter Dosiskontakt 36 zu sehen, die mit den entsprechenden Knöpfen korrespondieren. Ein Verabreichungskontakt 19, der mit dem Verabreichungsknopf 18 korrespondiert, ist ebenfalls zu sehen.In 3 are a prefill contact 30 , an activation contact 32 , a first dose contact 34 and a second dose contact 36 to see that correspond with the corresponding buttons. An administration contact 19 that with the administration button 18 corresponds, can also be seen.

Unter Bezugnahme auf 3 ist zu sehen, dass eine geeignete Stelle für eine Stromquelle 38, wie beispielsweise eine Batterie bzw. Batterien bereitgestellt ist. Es gibt auch einen geeigneten Bereich, in dem sich eine Kartusche 40 oder Ampulle mit Medikament befinden kann. Dieser Bereich ist über den lösbaren geformten Anteil 24 des Hauptgehäuses 4 zugänglich, damit die Kartusche 40 oder Ampulle, wie vom Anwender benötigt, gewechselt werden können.With reference to 3 is to see that a suitable place for a power source 38 , such as a battery is provided. There is also a suitable area where there is a cartouche 40 or ampoule with drug can be. This area is above the detachable molded portion 24 of the main housing 4 accessible to the cartridge 40 or ampoule, as required by the user, can be changed.

In einem dritten Bereich des Hauptgehäuses 4 ist ein Antriebsmechanismus 42 bereitgestellt, der von der Stromquelle 38 betrieben wird und auf die Kartusche 40 oder Ampulle mit Medikament wirkt.In a third area of the main housing 4 is a drive mechanism 42 provided by the power source 38 is operated and on the cartridge 40 or ampoule with medication acts.

Die Kartusche 40 oder Ampulle umfasst ein Behältnis 44 bzw. eine Hülse, das bzw. die an einem Ende von einer Abdeckung 46 an einem Kopfende davon verschlossen und an dem anderen von einem bewegbaren Spund 48 bzw. Stopper versiegelt ist. Wenn sie in Position ist, durchsticht die Nadeleinheit 22 die Abdeckung 46, und die Bewegung des Spunds 48 zu der Abdeckung 46 bewirkt, dass das in der Kartusche 40 oder Ampulle enthaltene Medikament ausgestoßen wird. Bei der Kartusche kann es sich um eine 3-ml-Kartusche in Übereinstimmung mit ISO/FDIS 11608 Teil 3 oder um eine beliebige andere, für den Injektor geeignete Kartusche handeln.The cartouche 40 or ampoule comprises a container 44 or a sleeve, which at one end of a cover 46 closed at one head end thereof and at the other by a movable bung 48 or stopper is sealed. When in position, the needle unit pierces 22 the cover 46 , and the movement of the bung 48 to the cover 46 causes that in the cartridge 40 or ampoule contained drug is expelled. The cartridge may be a 3 ml cartridge in accordance with ISO / FDIS 11608 Part 3 or any other cartridge suitable for the injector.

Die Bewegung des Spunds 48 oder Stoppers wird durch die Bewegung eines Kolbens oder Schaftes 50 verursacht, der einen Teil des Antriebsmechanismus 42 bildet. Der Kolben oder Schaft 50 ist zwischen einer vollständig zurückgezogenen Position (nicht gezeigt), welche den Austausch der Kartusche 40 oder Ampulle erlaubt, und einer zweiten vollständig erweiterten Position, in der so viel Medikament wie möglich aus der Kartusche 40 oder der Ampulle ausgestoßen wird, beweglich. In dem Hauptgehäuse 4 kann ein Endstoppschalter 52 bereitgestellt sein um zu erkennen, wenn der Kolben 50 sich in der vollständig zurückgezogenen Position befindet. Auslösen des Endstoppschalters 52 kann eine Greif- oder eine andere Verschlussvorrichtung freisetzen, um zum Austauschen der Kartusche 40 Zugang zu dem Hauptgehäuse 4 erhalten zu können.The movement of the bung 48 or stopper is by the movement of a piston or shank 50 causing a part of the drive mechanism 42 forms. The piston or shaft 50 is between a fully retracted position (not shown), which is the replacement of the cartridge 40 or ampoule allowed, and a second fully extended position, in which as much drug as possible out of the cartridge 40 or the ampoule is ejected, movable. In the main body 4 can be an end stop switch 52 be provided to detect when the piston 50 is in the fully retracted position. Triggering the end stop switch 52 may release a grasping or other closure device to replace the cartridge 40 Access to the main body 4 to be able to get.

Der Antriebsmechanismus 42 wird von einem Motor 54 unter der Kontrolle einer elektronischen Steuereinheit (nicht gezeigt) betrieben. Der Motor 54 sollte reversibel sein, damit der Kolben 50 zwischen der ersten und der zweiten Position bewegt werden kann. In 3 ist der Motor 54 zu sehen, um den Kolben 50 mit einem Zahnradpaar 42 derart anzutreiben, dass eine Drehung eines dritten Rotors 58 bewirkt, dass der Kolben 50 in Relation zu dem dritten Rotor bewegt wird.The drive mechanism 42 is from a motor 54 operated under the control of an electronic control unit (not shown). The motor 54 should be reversible to allow the piston 50 between the first and the second position can be moved. In 3 is the engine 54 to see the piston 50 with a gear pair 42 to drive such that a rotation of a third rotor 58 causes the piston 50 is moved in relation to the third rotor.

Vorzugsweise kann der Benutzer die Vibration des Motors 54 und des assoziierten Antriebsmechanismus 42 in Betrieb fühlen und/oder hören. Auf diese Weise erhält der Benutzer einen höheren Grad an Vertrauen bei Betrieb des Injektors 2.Preferably, the user can vibration the engine 54 and the associated drive mechanism 42 feel and / or hear in operation. In this way, the user gets a higher degree of confidence in operating the injector 2 ,

Die Funktionalität eines schreibstiftartigen Injektors in Übereinstimmung mit der vorliegenden Erfindung wird nun insbesondere unter Bezugnahme auf 1, 2 und 3 beschrieben.The functionality of a pen-type injector in accordance with the present invention will now be particularly appreciated with reference to FIG 1 . 2 and 3 described.

Der Injektor 2 ist mit einer elektronischen Steuereinheit ausgestattet. Die elektronische Steuereinheit ist sowohl mit dem Antriebsmechanismus als auch mit einer Benutzeroberfläche gekoppelt. Die Benutzeroberfläche umfasst das Anzeigefeld 10 sowie die vom Benutzer bedienbaren Knöpfe (und assoziierte Kontakte). Die elektronische Steuereinheit beruht auf einem Mikroprozessor. Zur Speicherung des „Dosisverlaufs" und patientenspezifischer Informationen kann ein flüchtiger Speicher oder ein permanenter Speicher verwendet werden.The injector 2 is equipped with an electronic control unit. The electronic control unit is coupled to both the drive mechanism and a user interface. The user interface includes the display field 10 and user-operable buttons (and associated contacts). The electronic control unit is based on a microprocessor. To store the "dose history" and patient-specific information, a volatile memory or a permanent memory can be used.

Die elektronische Steuereinheit wird vorzugsweise von der Stromquelle 38 des Injektors mit Strom versorgt.The electronic control unit is preferably from the power source 38 powered by the injector.

Der Injektor 2 umfasst vorzugsweise auch einen Anschluss zur Kommunikation zwischen der elektronischen Steuereinheit und einer externen Vorrichtung wie beispielsweise einem PC.The injector 2 preferably also includes a port for communication between the electronic control unit and an external device such as a personal computer.

Der Injektor 2 weist außerdem eine Vorfüllerkennungseinrichtung auf (beispielsweise einen Neigungsschalter oder einen Beschleunigungsmesser) um zu identifizieren, wenn der Injektor 2 umgedreht wird. Bei Feststellung einer umgekehrten Position (Nadel nach oben) verändert der Injektor 2 automatisch den Zustand, um für das Vorfüllen bereit zu sein. Das Vorfüllen kann durch Drücken des Vorfüllknopfes 26 ausgelöst werden, um eine feste kleine Verabreichungsaktion zu verursachen. Die elektronische Steuereinheit kann bewirken, dass ein Lautsprecher einen Ton abgibt, wenn der Vorfüllknopf 26 gedrückt wird.The injector 2 also includes a prefill detection device (eg, a tilt switch or an accelerometer) to identify when the injector 2 is turned around. If an inverted position (needle up) is detected, the injector changes 2 automatically the state to be ready for pre-filling. The priming can be done by pressing the prefill button 26 be triggered to cause a fixed small administration action. The electronic control unit may cause a speaker to sound when the prefill button 26 is pressed.

Der Vorfüllknopf 26 ist zu jedem anderen Zeitpunkt inaktiv. Wenn der Vorfüllknopf 26 aktiv ist, sind alle anderen Knöpfe im Steuerfeldbereich inaktiv, das heißt solche Knöpfe, die verwendet werden, um eine Dosis einzustellen oder zu verabreichen.The priming button 26 is inactive at any other time. When the priming button 26 is active, all other buttons in the panel area are inactive, that is, buttons used to adjust or administer a dose.

Die elektronische Steuereinheit kann bewirken, dass ein Lautsprecher einen Ton abgibt, wenn der Aktivierungsknopf 16 ausreichend lange gedrückt wird, um für den Benutzer akustische Rückmeldung zu geben.The electronic control unit may cause a speaker to sound when the activation button 16 is pressed long enough to give the user acoustic feedback.

Der Aktivierungsknopf 16 hat die Funktion, den Verabreichungsknopf 18 zu aktivieren. Der Aktivierungsknopf wird vorzugsweise für einen vorbestimmten Zeitraum nach unten gehalten, bevor der Injektor 2 aktiviert wird. Der aktivierte Zustand kann des Weiteren auf dem Anzeigefeld 10 gezeigt sein. Die Funktionalität des Aktivierungsknopfes ist mit dem Abdeckungserkennungsschalter 28 derart verknüpft, dass die Aktivierungstaste 16 den Injektor 2 nur aktivieren kann, wenn die Abdeckung 6 nicht vorhanden ist.The activation button 16 has the function, the administration button 18 to activate. The activation button is preferably for a vorbe agreed period kept down before the injector 2 is activated. The activated state can also be displayed on the display 10 be shown. The functionality of the activation button is with the cover detection switch 28 linked so that the activation key 16 the injector 2 can only activate when the cover 6 not available.

Darüber hinaus erkennt in einer bevorzugten Ausführungsform eine Uhr in der elektronischen Steuereinheit, ob der Verabreichungsknopf 18 innerhalb eines bestimmten Zeitintervalls nach dem Aktivieren des Injektors 2 gedrückt worden ist. Wird der Verabreichungsknopf 18 nicht innerhalb des festgelegten Zeitintervalls gedrückt, deaktiviert die elektronische Steuereinheit den Injektor 2. Alternativ wird der Injektor deaktiviert, wenn die Aktivierungstaste innerhalb eines vorbestimmten Zeitraumes vom Benutzer ein zweites Mal gedrückt wird.In addition, in a preferred embodiment, a clock in the electronic control unit detects whether the delivery button 18 within a certain time interval after activating the injector 2 has been pressed. Will the administration button 18 not pressed within the specified time interval, the electronic control unit deactivates the injector 2 , Alternatively, the injector is deactivated when the activation key is pressed a second time within a predetermined period of time by the user.

In einer alternativen Ausführungsform kann der Dosisknopf 18 sowohl als ein Vorfüllknopf als auch als der Dosisknopf fungieren. Wenn der Vorfülldetektor von dem aufwärts zur Nadel gerichteten Injektor 2 betätigt wird, würde sich die Funktion des Dosisknopfes 18 zu der eines Vorfüllknopfes der vorherigen Ausführungsform ändern.In an alternative embodiment, the dose button 18 both as a prefill button and as the dose button. When the prefill detector from the injector directed upwards to the needle 2 is pressed, the function of the dose button would be 18 to that of a prefill button of the previous embodiment.

Die Knöpfe des Injektors 2 sind vorzugsweise von taktiler Art, um dem Benutzer sensorische Rückmeldung zu geben.The buttons of the injector 2 are preferably of a tactile nature to provide sensory feedback to the user.

Das Anzeigefeld 10 ist typischerweise eine LCD-Anzeige und liefert alphanumerische und graphische Informationen in Bezug zu dem Betrieb der Vorrichtung. Das Anzeigefeld 10 zeigt vorzugsweise die ausgewählte Dosismenge, die vorherige Dosismenge und den Zeitraum an, der seit Verabreichung der vorherigen Dosis verstrichen ist. Typischerweise ist die Zeit, die seit der vorherigen Dosis verstreicht, auf einen Zeitraum innerhalb der vorangehenden 48 Stunden beschränkt, obgleich andere Zeiträume möglich sind.The display field 10 is typically an LCD display and provides alphanumeric and graphical information related to the operation of the device. The display field 10 preferably indicates the selected dose amount, the previous dose amount, and the time elapsed since the previous dose was administered. Typically, the time elapsed since the previous dose is limited to a period within the previous 48 hours, although other periods are possible.

Zusätzliche Informationen, die angezeigt werden können, umfassen:

  • – dass der Injektor aktiviert und bereit zur Verabreichung ist (graphisch);
  • – dass der Injektor verabreicht (graphisch);
  • – dass der Injektor die ausgewählte Dosis verabreicht hat und dass ein Benutzer warten soll, bevor er die Nadel aus seinem Körper entfernt;
  • – dass dieser Wartezeitraum verstrichen ist;
  • – den Dosisverlauf, typischerweise für die letzten 48 Stunden, was die verwendete Dosierung und die verstrichene Zeit zwischen Dosen anbelangt;
  • – die Menge an Medikament, die in der Kartusche verbleibt, vorzugsweise als Dosiseinheiten des Medikamentes;
  • – dass sich die Vorrichtung in der Vorfüllposition befindet (entweder zusätzlich zu oder anstelle der oben erwähnten akustischen Anzeige);
  • – die Einstellung der Lautstärke des Lautsprechers, beispielsweise laut, leise oder stumm;
  • – dass die Lebensdauer des Injektors fast abgelaufen ist (beispielsweise eine Anzeige des Ladezustandes der Batterie – graphisch oder Zeitkontrolle der Anzahl von Tagen oder vollständigen Betriebszyklen bis zu einer vorbestimmten Produktlebensdauer – alphanumerisch);
  • – dass die Nadel möglicherweise blockiert ist;
  • – dass die Kartusche 40 gerade gewechselt wird;
  • – dass die ausgewählte Dosis das in der Kartusche 40 verfügbare Maximum ist;
  • – dass die maximal verfügbare Dosis weniger als die erwartete Dosis ist.
Additional information that may be displayed includes:
  • - that the injector is activated and ready for administration (graphically);
  • - that the injector administered (graphically);
  • - that the injector has administered the selected dose and that a user should wait before removing the needle from his body;
  • - that this waiting period has elapsed;
  • - the course of the dose, typically for the last 48 hours, as regards the dose used and the time elapsed between doses;
  • The amount of medicament remaining in the cartridge, preferably as dosage units of the medicament;
  • - That the device is in the prefill position (either in addition to or instead of the above-mentioned acoustic display);
  • - the volume of the loudspeaker, for example loud, soft or mute;
  • - that the life of the injector has almost expired (for example, an indication of the state of charge of the battery - graphically or time control of the number of days or complete cycles of operation up to a predetermined product life - alphanumerically);
  • - that the needle may be blocked;
  • - that the cartridge 40 just changed;
  • - that the selected dose is that in the cartridge 40 is available maximum;
  • - that the maximum available dose is less than the expected dose.

Das Anzeigefeld 10 kann einem Benutzer eine Wahl von Sprachoptionen wie geeignet für den Markt und/oder Benutzer anbieten. Der angezeigte Text kann das oben Erwähnte und/oder weitere Informationen umfassen. Die Sprachoption kann vorprogrammiert oder von einem Benutzer wählbar sein. Der Benutzer kann die Sprachoption vorzugsweise mittels eines auf dem Anzeigefeld 10 bereitgestellten Menüs wählen.The display field 10 may offer a user a choice of language options as appropriate for the market and / or user. The displayed text may include the above and / or other information. The language option may be preprogrammed or selectable by a user. The user may prefer the voice option by means of one on the display panel 10 select provided menus.

Der aktuell ausgewählte Dosiswert, der zuvor verwendete Dosiswert und die Zeit (in Stunden) seit Verabreichung der vorherigen Dosis können alle deutlich zur selben Zeit in großen, leicht lesbaren Zeichen auf der Anzeige gezeigt werden. Vorzugsweise ist die Anzeige außerdem mit einer Hintergrundbeleuchtung ausgestattet.Of the currently selected Dose value, previously used dose value and time (in hours) since Administration of the previous dose can all be clearly at the same Time in big, easily readable characters are shown on the display. Preferably the message as well equipped with a backlight.

Die Anzeige 10 stellt vorzugsweise eine graphische Anzeige bereit, dass die ausgewählte Dosis gerade verabreicht wird. Dies kann beispielsweise als animierte Graphik oder als Zeitkontrolle erreicht werden (oder durch eine Kombination aus beidem).The ad 10 preferably provides a graphic display that the selected dose is being administered. This can be achieved, for example, as animated graphics or as a time control (or a combination of both).

Die Steuerknöpfe haben eine Reihe von Funktionen. Die Dosisknöpfe 12, 14 gestatten einem Benutzer die Auswahl einer gewünschten Dosis. Der Dosisaktivierungsknopf 16 gestattet einem Benutzer die Bestätigung der Auswahl einer gewünschten Dosis. Der erste Dosisknopf kann die Dosierungsstufe stufenweise erhöhen und der zweite Dosisknopf kann die Dosierungsstufe stufenweise verringern. Die Dosiswählknöpfe 12, 14 können gedrückt werden (und für kurze Zeit, 1-2 Sekunden, gehalten werden), um einen Dosiswert wieder auf null zu setzen. Der Benutzer kann dann in einzelnen (bzw. halben) Stufen nach oben (oder unten) wählen.The control buttons have a number of functions. The dose buttons 12 . 14 allow a user to select a desired dose. The dose activation button 16 allows a user to confirm the selection of a desired dose. The first dose button may gradually increase the dosage level and the second dose button may gradually decrease the dosage level. The dose selector buttons 12 . 14 can be pressed (and held for a short time, 1-2 seconds) to reset a dose level to zero. The user can then select upwards (or downwards) in individual (or half) levels.

Die Dosiswählknöpfe 12, 14 sollen für eine einzelne (oder halbe) Stufe in dem gewählten Dosiswert einmal gedrückt werden. In einer alternativen Ausführungsform bewirkt Drücken und Halten eines der Knöpfe, dass der Dosiswert (nach oben oder unten) rollt, um die Dosisgröße schneller zu verändern.The dose selector buttons 12 . 14 should be pressed once for a single (or half) step in the selected dose level. In an alternative embodiment, pressing and holding one causes the buttons that the dose value scrolls (up or down) to change the dose size faster.

Der Verabreichungsknopf 18 gestattet einem Benutzer, die Verabreichung der Dosierung auszulösen. Der Vorfüllknopf 26 verabreicht eine Einheit der Dosis aus der Kartusche 40. Wenn daher in dem Injektor 2 etwaige Luft eingeschlossen ist, kann diese durch Verwendung des Vorfüllknopfes 26 ausgestoßen werden. Eine Türausklinknase ist bereitgestellt, um Zugang zu der Kartusche 40 zu gewähren.The administration button 18 allows a user to initiate the administration of the dosage. The priming button 26 administered a unit of the dose from the cartridge 40 , Therefore, if in the injector 2 Any air trapped may be removed by using the pre-fill button 26 be ejected. A door latch nose is provided to access the cartridge 40 to grant.

Claims (5)

Injektionsvorrichtung, welche einen Antriebsmechanismus (42) aufweist, um selektiv eine Dosis eines Medikaments von einer Medikamentenkartusche (40) durch eine Nadeleinheit (22) auszustoßen, eine elektronische Kontrolleinheit, um den Antriebsmechanismus (42) zu steuern, und einen Verabreichungsknopf (18), um ein Verabreichungsknopfsignal für die elektronische Steuereinheit zu erzeugen, welches die auszustoßende Dosis angibt, wobei ein Aktivierungsknopf (16) verursacht, dass ein erstes Aktivierungsknopfsignal an die elektronische Steuereinheit gesendet wird, um zu ermöglichen, dass die Dosis ausgestoßen wird, wobei der Aktivierungsknopf (16) mit einem Abdeckungserkennungsschalter (28) verbunden ist, so dass der Aktivierungsknopf nur dann funktioniert, um einen Injektor (2) zu aktivieren, wenn keine Abdeckung (6) vorhanden ist.Injection device comprising a drive mechanism ( 42 ) to selectively dose a drug from a drug cartridge ( 40 ) by a needle unit ( 22 ), an electronic control unit to control the drive mechanism ( 42 ) and an administration button ( 18 ) to generate a delivery button signal for the electronic control unit indicating the dose to be delivered, wherein an activation button ( 16 ) causes a first activation button signal to be sent to the electronic control unit to enable the dose to be expelled, with the activation button ( 16 ) with a cover detection switch ( 28 ), so that the activation button only works to an injector ( 2 ), if no cover ( 6 ) is available. Injektionsvorrichtung gemäß Anspruch 1, dadurch gekennzeichnet, dass, wenn das Verabreichungsknopfsignal nicht innerhalb einer vorher bestimmten Zeitspanne zum Aktivierungssignal erzeugt wird, die elektronische Steuereinheit den Antriebsmechanismus (42) nicht in Reaktion auf das Verabreichungsknopfsignal betätigt.Injection device according to claim 1, characterized in that, if the administration button signal is not generated within a predetermined period of time for the activation signal, the electronic control unit controls the drive mechanism (10). 42 ) is not actuated in response to the administration button signal. Injektionsvorrichtung gemäß Anspruch 1 oder Anspruch 2, dadurch gekennzeichnet, dass der Aktivierungsknopf das erste Aktivierungsknopfsignal eine vorher bestimmte Zeitspanne lang erzeugen muss, bevor die elektronische Steuereinheit auf das Verabreichungsknopfsignal reagiert.Injection device according to claim 1 or claim 2, characterized in that the activation button is the first Has to generate the activation button signal for a predetermined period of time, before the electronic control unit on the administration button signal responding. Injektionsvorrichtung gemäß einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Injektionsvorrichtung zusätzlich mit einem Anzeigefeld (10) versehen ist, wobei das Anzeigefeld (10) eine Angabe bereitstellt, dass es der Dosis ermöglicht wird, ausgestoßen zu werden.Injection device according to one of claims 1 to 3, characterized in that the injection device additionally with a display panel ( 10 ), the display field ( 10 ) provides an indication that the dose is allowed to be expelled. Injektionsvorrichtung gemäß einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass, wenn der Aktivierungsknopf ein nachfolgendes Aktivierungsknopfsignal innerhalb einer vorher bestimmten Zeitspanne zum ersten Aktivierungsknopfsignal erzeugt, die elektronische Steuereinheit den Antriebsmechanismus (42) in Reaktion auf das Verabreichungsknopfsignal nicht betätigt.Injection device according to one of claims 1 to 4, characterized in that, when the activation button generates a subsequent activation button signal within a predetermined time period to the first activation button signal, the electronic control unit the drive mechanism ( 42 ) is not actuated in response to the administration button signal.
DE60127303.6T 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT Expired - Lifetime DE60127303T3 (en)

Applications Claiming Priority (4)

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GBGB0031466.6A GB0031466D0 (en) 2000-12-22 2000-12-22 Improvements in and relating to an injection device
GB0031466 2000-12-22
EP01272097.5A EP1349593B2 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005711 WO2002051479A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit

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DE60112326T Expired - Lifetime DE60112326T2 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
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DE60119164T Expired - Lifetime DE60119164T2 (en) 2000-12-22 2001-12-21 DOSAGE FOR AN INJECTION DEVICE
DE60112472.3T Expired - Lifetime DE60112472T3 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
DE60123836T Expired - Lifetime DE60123836T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DE60110636T Expired - Lifetime DE60110636T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DE60110638T Expired - Lifetime DE60110638T2 (en) 2000-12-22 2001-12-21 WRIST-STICK INJECTOR WITH HOLDING DEVICE FOR MEDICATION CONTAINERS
DE60110463T Expired - Lifetime DE60110463T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DE60110642T Expired - Lifetime DE60110642T2 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTION DEVICE WITH AN ELECTRONIC CONTROL UNIT
DE60110639T Expired - Lifetime DE60110639T2 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
DE60127303.6T Expired - Lifetime DE60127303T3 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
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DE60119164T Expired - Lifetime DE60119164T2 (en) 2000-12-22 2001-12-21 DOSAGE FOR AN INJECTION DEVICE
DE60112472.3T Expired - Lifetime DE60112472T3 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
DE60123836T Expired - Lifetime DE60123836T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DE60110636T Expired - Lifetime DE60110636T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DE60110638T Expired - Lifetime DE60110638T2 (en) 2000-12-22 2001-12-21 WRIST-STICK INJECTOR WITH HOLDING DEVICE FOR MEDICATION CONTAINERS
DE60110463T Expired - Lifetime DE60110463T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DE60110642T Expired - Lifetime DE60110642T2 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTION DEVICE WITH AN ELECTRONIC CONTROL UNIT
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